A Prospective Interventional Study of Stereotactic Body RadioTherapy (SBRT) With Continuous Tracking for Inoperable Patients With Primary and Secondary Renal Cancer (SBRTRC)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Acute toxicity
研究概览
简要总结
This is a prospective, interventional, monocentric, clinical study of Stereotactic Body Radiation Therapy (SBRT) for primary or secondary renal tumors, delivering from 25-26 Gy/1 fraction to 42-48 Gy/3-4 fractions or 40-50 Gy/5 fractions (standard prescriptions for the internationl guidelines, according to tumor size), using a robotic accelerator -CyberKnife® (Accuray, Sunnyvale, CA)-, with fiducial-tracking, to observe the acute and late toxicity reduction (as primary objectives), due to the maximum precision of the treatment. Secondary objectives are Local Relpase-Free Survival (LRFS), Regional Relapse-Free Survival (RRFS), Distant Metastasis-Free Survival (DMFS), Disease-Free Survival (DFS), Cancer Specific Survival (CSS), Overall Survival (OS) and Quality-of-Life (QoL). A total of 60 participants are expected to be enrolled over four years, and the follow-up of enrolled patients will be three years.
详细描述
Renal Cell Carcinoma (RCC) is the eighth most common cancer diagnosed in Europe, with a rising incidence, particularly in old patients. The standard of care for operable patients with primary RCC is surgical resection, however, not all patients are suitable candidates for surgery. Alternative approaches, such as thermal ablation, present significant limitations, as reduced efficacy for lager tumors (>3-4 cm) and those located near the renal hilum.
Traditionally, Radiotherapy (RT) has not been considered an effective treatment for RCC due to its perceived radioresistance. High dose radiation therapy RCC leads to both direct cancer cell death and indirect cancer death from vasculature disruption.
The paradigm of radioresistance has shifted significantly with the advent of stereotactic body radiotherapy/ ablative radiotherapy (SBRT/SABR), which has demonstrated promising efficacy in local control while preserving renal function. The radiosensitivity varies in laboratory studies, with low α/β values (2.6 Gy - 6.9 Gy), thus RCC's lines are more responsive to increased radiation fraction size.
SBRT is non-invasive, delivers high doses with precision, using a steep dose gradient over a small number of treatment sessions. This approach has recently demonstrated promising local control (LC), and acceptable toxicity, even for large tumors.
IROCK (the International Radiosurgery Consortium of the Kidney) included 223 patients pooled from nine institutions, with a median follow up of 30 months. No difference in LC and toxicity was observed between patients receiving single fraction SBRT at 25 Gy (range 14-26 Gy) and multiple fractions SBRT at a median of 40 Gy (range 24-70 Gy) in four fractions was observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or clinical diagnosis of primary or secondary kidney tumors
- •Patients aged ≥18 years
- •Signed informed consent
- •Tumor up to 10 cm in the greatest diameter (sum of diameters in case of multiple lesions)
- •PS (ECOG) ≤2
- •No prior local radiotherapy
- •Fertile women using contraception methods previously initiated (a pregnancy test will be prescribed)
排除标准
- •Patients aged < 18 years
- •Tumors > 10 cm
- •Psychiatric or other disorders that may prevent the patient from signing informed consent
- •Previous invasive cancer, except for skin cancer (excluding melanoma) unless the patient has been disease-free for at least 3 years (e.g., carcinoma in situ of the oral cavity or bladder)
- •Pregnant women
- •Collagen diseases
- •Sjogren's syndrome
结局指标
主要结局
Acute toxicity
时间窗: 3 months
Acute toxicity grade ≥2 as the maximum toxicity value at 3 months after the completion of radiotherapy treatment evaluated with Common Toxicity Criteria For Adverse Events (CTCAE) scale, v6.0, with 5 grades, from 0 = no change, to 5 = death for toxicity
Late toxicity
时间窗: 3 years
Late toxicity grade ≥2 as the maximum toxicity value at 3 years after the completion of radiotherapy treatment evaluated with Common Toxicity Criteria For Adverse Events (CTCAE) scale, v6.0, with 5 grades, from 0 = no change, to 5 = death for toxicity
次要结局
- Cancer Specific Survival (CSS)(3 years)
- Local control of the treated lesion (LC)(3 years)
- Local Relapse-Free Survival (time to local recurrence, LRFS)(3 years)
- Regional Relapse-Free Survival (RRFS)(3 years)
- Distant Metastases-Free Survival (DMFS)(3 years)
- Disease-Free Survival (local, regional, distant, DFS)(3 years)
- Overall Survival (OS)(3 years)
研究者
Nadia Di Muzio
Professor
IRCCS San Raffaele